Pharmacy Law Module 1 Flashcards
Any individual who helps a person to violate the law either directly or indirectly.
accessory
Regulations set forth by governmental agencies, such as the Internal Revenue Service (IRS) and the Social Security Administration (SSA); also called regulatory law.
administrative law
Tampering with or contaminating a product or substance.
adulterated
Drugs derived from barbituric acid, which act as central nervous system depressants.
barbiturates
A discipline dealing with the ethical and moral implications of biological research and applications.
bioethics
Rules and regulations that govern the relationship between individuals within society.
civil law
A violation of the law.
crime
An individual who violates the law.
criminal
Rules and regulations that govern the relationship of the individual to society as a whole.
criminal law
A federal law enforcement agency that combats illegal drug use and smuggling both within the United States and abroad.
Drug Enforcement Administration (DEA)
A serious crime, such as murder, kidnapping, assault, or rape, that is punishable by imprisonment for more than one year.
felony
The agency within the U.S. Department of Health and Human Services that is responsible for assurance of the safety, efficacy, and security of drugs used for humans and pets, biological products, medical devices, cosmetics, radioactive products, and the national food supply.
Food and Drug Administration (FDA)
A rule or regulation established by a governing body.
law
Professional misconduct, or the demonstration of an unreasonable lack of skill, resulting in injury, loss, or damage to a patient.
malpractice
The discipline in which merits, risks, and social concerns are evaluated concerning the practice of medicine.
medical ethics
Fraudulent labeling or marking.
misbranding
A crime less serious than a felony, punishable by a fine or imprisonment for less than one year.
Misdemeanor
A unique and permanent product code assigned to each new drug as it becomes available in the marketplace; it identifies the manufacturer or distributor, the drug formulation, and the size and type of its packaging.
National Drug Code (NDC)
A database of officially recognized drug names.
National Formulary (NF)
A type of unintentional tort alleged when a person has performed, or failed to perform, an act that a reasonable person would, or would not, have performed in similar circumstances.
negligence
A drug that is developed for small populations of people in need of the drug.
orphan drug
Regulations set forth by governmental agencies. It is also called administrative law.
Regulatory law
Under HIPAA, “codes used to encode data elements, tables of terms, medical concepts, diagnostic codes, or medical procedure.” A code set includes the codes and descriptors of the codes.
standard code sets
Established by authority, custom, or general consent as a model or example; something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality.
standards
Rules and regulations resulting from decisions by legislatures.
statutes
A civil wrong committed against person or property.
tort
This refers to a patient who does not follow medical advice, and, therefore, becomes responsible for any problems that occur as a result of his or her decision.
Assumption of risk
The person or group against whom charges are brought in a court action.
defendant
An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony.
deposition
A written set of questions that must be answered under oath as if in a court, within a specific period.
Interrogatory
The power, right, and authority given to a court to hear a case and to make a judgment.
jurisdiction
A party to a lawsuit.
Litigant
lawsuit or a contest in court.
Litigation
The person who files a lawsuit initiating a civil legal action. In criminal actions, the prosecution (government) is the plaintiff, acting on behalf of the people.
plantiff
The law that limits the period during which a person can sue. The period varies from one to three years.
statue of limitations
A court order that requires an individual to appear as a witness in court or to make himself or herself available to be deposed.
subpoena
Dishonest and deceitful practices undertaken to induce someone to part with something of value or legal right.
A pharmacist or a technician promises patients “miracle cures” or accepts fees from patients for spiritual powers to heal.
Fraud
Defamatory writing, such as published material, or pictures that injure the reputation of another.
A pharmacy advertises that a competing pharmacy does not stock medications of the same quality.
Libel
Spoken words that jeopardize someone’s reputation or means of livelihood.
A pharmacy worker tells a customer that another pharmacy’s staff is not qualified.
Slander
Failure to use a reasonable amount of care to prevent injury or damage to another.
A pharmacist or technician fails to exercise ordinary care, and a patient is harmed.
Negligence
The improper use of equipment, a substance (such as a drug), or a service (such as a program).
A patient is harmed because a pharmacy worker gives him or her the wrong substance, strength, amount, or type of medication.
Abuse
True or False:
There have always been laws controlling drug manufacturing.
False
True or False:
The Pure Food and Drug Act established the Food and Drug Administration.
False
True or False:
If a drug is prepared and packed in unsanitary conditions, it is considered adulterated and not fit for sale.
True
True or False:
All drug labels must have information on the manufacturer and packer, but not the distributor.
False
True or False:
All drug manufacturers must file a new drug application if they want to market a new drug
True
Child-resistant containers should not be able to be opened by _____ of children under age 5.
80%
Which of the following is NOT an exception to the requirement for child-resistant containers?
Oral contraceptives
Inhalation aerosols
Sublingual nitroglycerin
Hypertension medications
Hypertension medications
A National Drug Code is made up of a minimum of _____ characters identifying manufacturer or distributor, drug formulation, and packaging size and type.
10
A(n) _____ drug is for patients with a rare disease or condition.
orphan
_____ drugs don’t have to go through the same scientific review on safety and effectiveness as brand name drugs.
Generic
More than _____ percent of prescriptions in community pharmacies are dispensed with generic drugs.
60
This act prohibits re-importation of a drug into the United States by anyone except the manufacturer.
Prescription Drug Marketing Act
According to the Omnibus Budget Reconciliation Act of 1987, nursing home residents should not be given _____ medications
unnecessary
True or False:
A drug manufacturer must now pay a fee to the FDA with a new drug application
True
True or False?
All anabolic steroids are manufactured and sold legally.
False
True or False:
A pharmacy only has to track drugs that it distributes, not medical devices like syringes.
False
True or False:
If the FDA wants to remove a dietary supplement from the market, it must hold public hearings to prove the supplement is unsafe.
True
With HIPAA, _____ is no longer considered a pre-existing condition.
pregnancy
_____ benefits allow an employee to continue current medical coverage for up to 18 months.
COBRA
If a pharmacy technician tells a friend information about a patient, the technician can be ____
terminated
The Medicare Modernization Act is better known as _____.
Medicare Part D
The MMA provides _____ for patients with economic hardships or who are on high-cost medication
drug coverage
An insurance option that allows the individual patient to make their own medical choices, like which physician to see, is called _____.
a health savings account
Under the Combat Methamphetamine Epidemic Act, products containing pseudoephedrine and ephedrine purchases are limited to a maximum amount in any _____ period.
30 day
Prescriptions that are paid through Medicaid must be written on a _____ prescription pad.
tamper resistent
Risk Evaluation and _____ Strategies (REMS) is a safety protocol designed to identify risks associated with particular drugs or biologics to determine if the benefits outweigh the risks.
Mitigation
The mission of the DEA is to enforce ____________________ laws and regulations.
controlled substance
The ____________________ is a unique and permanent product code that identifies the manufacturer or distributor, the drug formulation, and the size and type of packaging.
National Drug Code
A Class II Drug Recall is one in which:
the use or exposure to the product may cause temporary or medically reversible adverse health hazards.
Which drug is an example of a Schedule V drug that requires a prescription?
Lomotil
Guidelines for practice of a profession developed by professional organizations are also called ____________________.
standards
Schedule V agents have the lowest abuse potential of all the controlled substances.
true
Pharmacies utilize DEA form ____________________ to report loss or theft of significant amounts of controlled substances.
DEA-106
When the use of or exposure to a drug will cause severe adverse reactions or death, and the drug is recalled, it is classified as a(n) ____________________ drug recall.
Class 1
An oral testimony taken by a court reporter at a location outside the courtroom, subject to the same requirements for truth as court testimony is called:
deposotion
The FDA is a branch of the U.S. Department of Health and ____________________ Services.
human
The ________________ was passed to update the labeling on prescription medications.
Food and Drug Administration Modernization Act
A pharmacy must maintain records of controlled substances dispensed for ____________________ years, although some states require pharmacies to maintain records for at least five years.
2
The study of values or principles governing personal relationships is called:
ethics
An ___________ is one that is intended for use in a few patients with a rare disease or condition affecting less than 200,000 people.
orphan drug act
True or False
A crime in a pharmacy in which the pharmacist was illegally selling prescription drugs without a prescription would be classified as a felony.
True
Which of the following amendments or acts required manufacturers to register and list their products?
Medical Device Ammendment
The federal regulatory agency for the field of pharmacy is the ____________________.
FDA
The regulation of the practice of pharmacy is primarily a function of the ____________________ and not the federal government.
state
Which of the following laws is an extension of the Patriot Act?
Combat Methamphetamine Epidemic Act
Which act prohibits the reimportation of a drug into the United States by anyone but the manufacturer?
Prescription Drug Marketing Act
The purpose of the ___________ was to prohibit the interstate transportation or sale of adulterated and misbranded food and drugs.
Pure Food and Drug Act of 1906
Which schedule is the opiate morphine, which may result in severe psychological and physical dependence when abused?
Schedule II
requires that drug products—both prescription and nonprescription—must be effective and safe
KefauverHarris Amendment of 1962
harmacies should make a complete and accurate record of all stocks of controlled substances on hand every:
two years
controls the manufacture, distribution, and dispensing of controlled substances
Comprehensive Drug Abuse Prevention and Control Act of 1970
prohibits dispensing of legend drugs without a prescription
Durham Humphrey Amendment of 1951
placed the burden of proof squarely on FDA with regard to the safeness of dietary supplements
Supplemental Health and Educational Act of 1994
prohibits the interstate distribution or sale of adulterated and misbranded food and drugs
Pure Food and Drug Act of 1906
offers tax breaks for companies to undertake the development and manufacture of drugs for uncommon diseases
Orphan Drug Act of 1983
created the Food and Drug Administration (FDA) and required pharmaceutical manufacturers to file a New Drug Application with the FDA
Food, Drug, and Cosmetic Act of 1938
The official DEA form that pharmacies use to document the destruction of controlled substances is form:
DEA-41
The ____________________ are administrative agencies that are authorized to make rules and regulations for the enforcement and administration of pharmacy law.
boards of pharmacy
Orphan drugs are used for all of the following disorders or conditions, except:
snakebite.
cystic fibrosis.
peptic ulcer.
blepharospasm.
peptic ulcer.
Orphan drugs are developed to be used for diseases that affect fewer than ____________________ people in the country.
two-hundred thousand
prohibits the reimportation of a drug into the United States
Prescription Drug Marketing Act of 1987
HIPAA stands for:
Health Insurance Portability and Accountability Act
A pharmacist must be registered with the DEA if he:
owns a pharmacy as a sole proprietor.
Who creates the standards for child-resistant packaging, as required by the Poison Prevention Packaging Act (PPPA)?
Consumer Product Safety Commission (CPSC)
The Model State Pharmacy Practice Act (MSPPA), which can provide a greater degree of uniformity between states with regard to the practice of pharmacy, was developed by the:
National Associations of Boards of Pharmacy (NABP).
An example of an intentional tort is:
battery.
Which of the following amendments or acts required manufacturers to register and list their products?
Medical Device Amendment
Kefauver–Harris Amendment
Durham–Humphrey Amendment
Omnibus Budget Reconciliation Act
Medical Device Amendment
True or False
The Medicare Prescription Drug, Improvement, and Modernization Act was designed to provide senior citizens and disabled individuals with a prescription drug benefit.
True
Applications for re-registration for a DEA license should be mailed approximately how many days prior to the expiration date?
60 days
Dishonest and deceitful practices undertaken in order to induce someone to part with something valuable or a legal right
fraud
defamatory spoken words
slander
improper use of equipment, a substance, or a service
abuse
failure to use a reasonable amount of care to prevent injury or damage to another
negligence
defamatory writing such as published material that injures the reputation of another
libel
Patient counseling, as required by the Omnibus Budget Reconciliation Act (OBRA) of 1990, should include:
the name and description of the drug.
laws that result from court decisions
judicial law
governs the relationship of the individual to society as a whole
criminal law
governs the relationship between individuals within society
civil law
results from action by the legislature
statues
the rules and regulations established by agencies of the federal government
administrative law
The Pure Food and Drug Act of 1906 was believed to be inadequate for the following reasons, except:
a manufacturer could not make false statements about a drug.
What regulatory agency is responsible for the approval of drugs, over-the-counter (OTC) and prescription labeling, and standards for drug manufacturing?
Food and Drug Administration (FDA)
The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires that pharmacists offer to discuss information about new and refill prescriptions with Medicare and ____________________ recipients.
Medicaid
True or False:
The Accutane iPledge Program is intended to prevent use of the drug during pregnancy due to the high risk of birth defects.
True
branch of the Department of Health and Human Services that controls all drugs for legal use
Food and Drug Administration (FDA)
creates standards for child-resistant packaging
Consumer Product Safety Commission (CPSC)
federal agency that provides facilities and services for the investigation, identification, prevention, and control of disease
Centers for Disease Control and Prevention (CDC)
federal agency whose mission is to enforce the controlled substance laws and regulations
Drug Enforcement Administration (DEA)
mission is to ensure workplace safety and a healthy environment within the workplace
Occupational Safety and Health Administration (OSHA)
A DEA number consists of a two-letter prefix followed by:
7 digits
Which information does not have to be included on a DEA Form 222 when ordering controlled substances?
Company name and address
Social security number
Ordering date
Signature of purchaser
SSN
Doctors and pharmacists are now required by the FDA to register and use a specific Web site in order to receive which of the following medications?
Isotretinoin (Accutane)
The maximum amount of items that may be ordered on DEA Form 222 is:
10
The agency deeply involved in the war against the human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) is the:
Centers for Disease Control and Prevention (CDC).
Schedule IV controlled substances include drugs with:
a low abuse potential such as certain hypnotics and minor tranquilizers.
HIPAA stands for:
Health Insurance Portability and Accountability Act
Prescriptions for Schedules III and IV controlled substances can be refilled:
up to five times in six months.
Retail pharmacies may request DEA permission to destroy outdated or damaged controlled substances ____________________ per year.
once
The DEA is part of the U.S. Department of ____________________.
Justice
Controlled substances have been categorized according to their potential for abuse and their ____________________ abilities.
addictive
